Manager, Regulatory Affairs - CMC

Manager, Regulatory Affairs - CMC

The incumbent is expected to be knowledgeable in project management principles, manufacturing change control management and CMC dossier structure with demonstrated ability to work with cross-functional project teams. The individual will be required to gather, review, update and report routine data and CMC related information and maintain regulatory tools and databases on a routine schedule to ensure visibility to the status of assigned activities.

As part of the Global Regulatory Affairs & Clinical Safety (GRACS) CMC Change Control & Dossier Management team, the CMC Submission Planning Scientist will be responsible for the integrated delivery of CMC submissions in alignment with program objectives by supporting the planning, preparation, and HQ release of regulatory submissions and administering associated GRACS-CMC system/process maintenance. The CMC Submission Planning Scientist will support progression of CMC submissions from authorization, assessment, project definition, execution and implementation by managing detailed CMC timelines and content deliverables in partnership with CMC product teams.

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

Your role at our organization is integral to helping the world meet new breakthroughs that affect generations to come, and we re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.

Primary responsibilities include, but are not limited to:

Qualifications

Skills